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Section B Changed Classes/Guidelines Final EPHMRA ANATOMICAL CLASSIFICATION GUIDELINES 2019 Section B Changed Classes/Guidelines Final Version Date of issue: 24th December 2018 1 A3 FUNCTIONAL GASTRO-INTESTINAL DISORDER DRUGS R2003 A3A PLAIN ANTISPASMODICS AND ANTICHOLINERGICS R1993 Includes all plain synthetic and natural antispasmodics and anticholinergics. A3B Out of use; can be reused. A3C ANTISPASMODIC/ATARACTIC COMBINATIONS This group includes combinations with tranquillisers, meprobamate and/or barbiturates except when they are indicated for disorders of the autonomic nervous system and neurasthenia, in which case they are classified in N5B4. A3D ANTISPASMODIC/ANALGESIC COMBINATIONS R1997 This group includes combinations with analgesics. Products also containing either tranquillisers or barbiturates and analgesics to be also classified in this group. Antispasmodics indicated exclusively for dysmenorrhoea are classified in G2X1. A3E ANTISPASMODICS COMBINED WITH OTHER PRODUCTS r2011 Includes all other combinations not specified in A3C, A3D and A3F. Combinations of antispasmodics and antacids are classified in A2A3; antispasmodics with antiulcerants are classified in A2B9. Combinations of antispasmodics with antiflatulents are classified here. A3F GASTROPROKINETICS r2013 This group includes products used for dyspepsia and gastro-oesophageal reflux. Compounds included are: alizapride, bromopride, cisapride, clebopride, cinitapride, domperidone, levosulpiride, metoclopramide, trimebutine. Prucalopride is classified in A6A9. Combinations of gastroprokinetics with other substances are classified here if used for dyspepsia or gastro-oesophageal reflux. A3G GASTRO-INTESTINAL SENSORIMOTOR MODULATORS r2019 Products which are specifically developed to modulate the multiple symptoms of irritable bowel syndrome (IBS). Includes alosetron, tegaserod. Linaclotide (290mcg) indicated for IBS-C (irritable bowel syndrome with constipation) is classified here; linaclotide (145mcg) indicated for chronic constipation is classified in A6A9. Products containing linaclotide for both chronic constipation and for IBS-C are classified here when there is no distinction by strength. Lubiprostone (8mcg) indicated for IBS-C is classified here; lubiprostone (24mcg) indicated for chronic constipation is classified in A6A9. Products containing plecanatide indicated for chronic constipation and IBS-C are classified here. Other drugs for constipation, including laxatives, are classified in A6A. 2 A6 DRUGS FOR CONSTIPATION AND BOWEL CLEANSERS r2014 Includes laxatives and other products for constipation. Products that are both laxatives and bowel cleansers are classified in the appropriate laxative class. For the classification of products indicated for irritable bowel syndrome with constipation (IBS-C) see A3G. A6A DRUGS FOR CONSTIPATION r2014 A6A1 Faecal softening laxatives r2015 Includes products containing softening laxatives such as liquid paraffin or docusate sodium. Combinations of faecal softening laxatives with osmotic laxatives are classified here. Combinations with bulk-forming laxatives are classified in A6A3. Combinations with stimulant laxatives are classified in A6A2. For castor oil products see A6A2. Glycerol suppositories are classified in A6A9. A6A2 Stimulant laxatives r2013 Includes products containing laxatives that have a stimulant effect on the intestinal membrane and peristalsis. Many of these are herbal, eg senna, or of herbal origin (anthraquinones, emodines, glycosides, etc). This group also includes phenolphthalein-derivatives, bisacodyl, and sodium picosulphate when used as a laxative. Products containing a stimulant laxative in combination with other laxative substances (except bulk-forming) are classified here. A6A3 Bulk-forming laxatives r2013 Includes products containing substances such as bran, ispaghula, methylcellulose, sterculia. Products containing a bulk-forming laxative in combination with other types of laxative are classified here. A6A4 Enemas R2015 Includes all products for constipation in enema form. Other rectal forms for constipation are classified as appropriate in the other constipation classes. Glycerol suppositories and effervescent suppositories are classified in A6A9. Combination packs containing an enema and another form are classified according to the other form. A6A5 Out of use D2013 3 A6A6 Osmotic laxatives I2013 Includes products containing osmotic laxatives. Substances include lactitol, lactulose, macrogols, magnesium citrate, magnesium hydroxide, magnesium sulphate, mannitol, sorbitol, etc. Combinations with other laxative substances are classified in A6A1, A6A2 and A6A3. Combinations with electrolytes that are present to ensure a neutral impact on electrolyte levels are classified in A6A7. A6A7 Osmotic laxatives with electrolytes I2013 Includes products containing osmotic laxatives in combination with electrolyte substances. These specific electrolytes are present to ensure a neutral impact on electrolyte levels. A6A9 Other drugs for constipation r2019 Includes other drugs for constipation and combinations of laxatives not classified in A6A1-A6A7. Combinations of laxatives with centrally acting anti-obesity substances are classified in A8A. Glycerol suppositories and effervescent suppositories are classified here. Prucalopride for chronic constipation is classified here. Linaclotide (145mcg) indicated for chronic constipation is classified here; linaclotide (290mcg) indicated for IBS-C (irritable bowel syndrome with constipation) is classified in A3G. Products containing linaclotide for both chronic constipation and for IBS-C are classified in A3G when there is no distinction by strength. Lubiprostone (24mcg) indicated for chronic constipation is classified here; lubiprostone (8mcg) indicated for IBS-C is classified in A3G. Products containing plecanatide and indicated for both chronic constipation and IBS-C are classified in A3G. 4 A7 INTESTINAL DISORDER PRODUCTS r2019 Products for functional gastro-intestinal disorders are in A3 and products for constipation and bowel cleansing are in A6. A7A INTESTINAL ANTI-INFECTIVES r2019 Includes all products containing one or more intestinal anti-infectives with or without other substances that are used for diarrhoea and/or hepatic encephalopathy. Sulphonamides and special antibacterials such as polymyxin, neomycin, vancomycin or colistin in oral form, when mainly indicated as antidiarrhoeals are included in this group. Combinations with motility inhibitors, intestinal adsorbants and micro-organisms are also included. Products containing rifaximin for either diarrhoea or hepatic encephalopathy are classified here. Products containing fidaxomicin for Clostridium difficile intestinal infections are classified here. A7B INTESTINAL ADSORBENT ANTIDIARRHOEALS r2011 Includes products such as kaolin and pectin. Combinations with micro-organisms are also included. A7C Out of use; can be reused. A7D Out of use; can be reused. A7E INFLAMMATORY BOWEL DISORDER PRODUCTS R2017 Includes products for inflammatory bowel disorders. Immunosuppressant products used for inflammatory bowel disorders as well as other conditions are classified in L4, for example in L4B (anti-TNF products). A7E1 Intestinal aminosalicylate products I2017 Includes products containing balsalazide, mesalazine, olsalazine, sulfasalazine and similar aminosalicylates for inflammatory bowel disorders. Products containing aminosalicylates and indicated for rheumatoid arthritis are classified in M1C. A7E2 Intestinal corticosteroid products I2017 Includes products containing corticosteroids for inflammatory bowel disorders. A7E9 Inflammatory bowel disorder products, other r2019 Includes other products for inflammatory bowel disorders. Products containing vedolizumab and indicated for inflammatory bowel disease only are classified here. Products containing disodium cromoglicate and indicated for food allergy are classified here. 5 Darvadstrocel (allogenic stem cells) for perianal fistulae in Crohn’s disease are classified here. 6 A7F ANTIDIARRHOEAL MICRO-ORGANISMS I1993 Includes micro-organisms such as lactobacillus acidophilus which are indicated for the treatment of diarrhoeal disease. Excluded are combinations with other antidiarrhoeals such as anti-infectives, motility inhibitors and intestinal adsorbents. A7G ORAL ELECTROLYTE REPLACERS I1993 Oral electrolyte replacers are included in this group where diarrhoeal disease has been indicated. Intravenous preparations are included in K. A7H MOTILITY INHIBITORS I1993 Includes narcotic derivatives such as loperamide, diphenoxylate and paregoric. Combinations with intestinal adsorbents and micro-organisms are also included. A7X INTESTINAL DISORDER PRODUCTS, OTHER r2019 Includes other products for intestinal disorders, including antidiarrhoeal products. 7 B BLOOD AND BLOOD FORMING ORGANS B1 ANTITHROMBOTIC AGENTS R1994 B1A VITAMIN K ANTAGONISTS R2004 Includes coumarin and indanedione derivatives. B1B HEPARINS R2004 B1B1 Unfractionated heparins Includes injectable high molecular weight (unfractionated) heparin (pure and in combination with other substances) with an average molecular weight from 5000 up to 30000 Dalton. The molecules are unfractionated. B1B2 Fractionated heparins R2003 Includes injectable low molecular weight (fractionated) heparin (pure and in combination with other substances) with an average molecular weight from 2000 up to 18000 Dalton. The molecules are fractionated (fragments). Included are, eg bemiparin, enoxaparin, tedelparin and tinzaparin. B1B3 Heparins for flushing Includes heparin
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